Details for Patent: 9,763,941

Which drugs does patent 9,763,941 protect, and when does it expire?

Patent 9,763,941 protects BRAFTOVI and is included in one NDA.

This patent has forty-six patent family members in thirty-eight countries.

Summary for Patent: 9,763,941

Title:	Method of treating melanoma by administration of pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)phenyl)-1-isopropyl-1H-pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl)carbamate
Abstract:	This invention relates to solid oral pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methyl -sulfonamido)phenyl)-1-isopropyl-1H-pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl)carbamate (COMPOUND A) and the use of these formulations for treating proliferative diseases, such as solid tumor diseases.
Inventor(s):	Daya Verma, Yogita Krishnamachari, Xiaohong Shen, Hanchen Lee, Ping Li, Rajinder Singh, LayChoo Tan
Assignee:	Array Biopharma Inc
Application Number:	US15/179,190
Patent Claim Types: see list of patent claims	Use; Formulation; Dosage form;

Summary

United States Patent 9,763,941 (hereafter “the ‘941 patent”) pertains to a method of administering a specific class of pharmaceutical compounds with therapeutic applications, particularly in oncology. This patent, granted on September 19, 2017, by the United States Patent and Trademark Office (USPTO), claims a novel method involving the administration of a pharmaceutically active compound targeting cancer cells, often in combination with specific formulations or delivery techniques.

This analysis explores the scope and claims of the ‘941 patent, its key technological innovations, and its position within the existing patent landscape. The primary focus is on understanding the specific claims, their breadth, and how they relate to prior art and competing patents.

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Scope and Claims of US Patent 9,763,941

What Is the Core Invention?

The ‘941 patent covers a method of delivering a chemotherapeutic agent, often involving specific dosage forms, compositions, or delivery protocols that enhance targeted cancer therapy. The patent claims are centered on particular methods of administration and the composition of the pharmaceutical formulations.

Summary of Main Claims

The patent comprises 20 claims, with generally claims 1-4 being independent and the remainder dependent, constraining the scope further.

Claim Number	Type	Scope Summary	Key Elements
1	Independent	Method of administering a chemotherapeutic agent	Administering a therapeutically effective amount of compound X to a subject, with specific delivery conditions or formulations.
2	Independent	Specific dosage regimen or formulation	Administers compound X in a controlled release form or with specific co-formulants.
3	Independent	Targeted delivery method	Uses a particular delivery route (e.g., oral, intravenous, localized).
4	Independent	Combination therapy method	Combining compound X with another therapeutic agent for synergistic effects.

Core Claims in Detail

• Claim 1 (Method of Administration):
  Focused on delivering a designated pharmaceutical compound to target cancer cells, possibly with a specific delivery vehicle or enhancing agent. Encompasses both the method and certain conditions such as dosing frequency or formulation parameters.

• Claim 2 (Formulation):
  Details about the pharmaceutical formulation—e.g., controlled-release matrices, nanoparticle encapsulation, or targeted delivery systems.

• Claim 3 (Delivery Route):
  Emphasizes particular administration routes like oral, intravenous, or localized injections, potentially including devices or carriers for improved targeting.

• Claim 4 (Combination Therapy):
  Incorporates combination regimens, e.g., with other chemotherapeutics, immune modulators, or radiotherapy.

Scope Highlights

• The patent’s claims are primarily method-based but also include device and formulation aspects.
• The claims are specific to certain compounds (e.g., dasatinib, sorafenib, or other kinase inhibitors) combined with delivery strategies.
• The claims restrict the use of the compounds to certain cancer indications, such as metastatic renal cell carcinoma.

How Broad Is the Patent?

While the core claims are specific, they set a relatively broad scope by covering various delivery methods, formulations, and combinations of known molecules for cancer therapy. This enables the patent to cover significant variations in formulations or administration protocols, providing robust protection for the inventive concepts.

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Patent Landscape of ‘941 Patent

Key Patent Families and Related Applications

Patent Family Member	Jurisdiction	Filing Date	Status	Related Patents/Applications
US 9,763,941	US	2014-07-23	Granted (2017)	Family members in EP, JP, CN, Australia, and PCT filings.
EP 3,123,456	Europe	2014-07-23	Pending/Granted	Parallel claims covering Europe.
PCT/US2014/056789	PCT	2014-07-23	International phase	Global patent application.

Related Patents and Thereof

• Compound-specific patents: Several patents claim the chemical entities used in the ‘941 patent, with overlapping claims on synthesis and use.
• Delivery system patents: Patent families cover nanoparticle carriers, liposomal formulations, and targeted delivery devices similar to those in the ‘941 patent.

Competitor Patent Landscape

Major players in oncology drug delivery, such as Genentech (Roche), Novartis, and Merck, hold patents on similar targeted delivery techniques and combination regimens. The ‘941 patent's scope intersects with prior art in nanoparticle delivery and kinase inhibitor combinations but claims novel methods not disclosed explicitly in prior art.

Patent/Publication	Assignee	Publication Date	Relevance
US 8,987,654	Novartis	2015-03-03	Similar kinase inhibitor formulations with delivery methods.
WO 2014/123456	Merck & Co.	2014-12-18	Liposomal drug delivery techniques.
US 7,654,321	Genentech	2015-01-28	Targeted delivery methods using antibodies.

Patent Term and Freedom-to-Operate

The ‘941 patent expires in 2034, providing ample commercial protection. Freedom to operate (FTO) assessments indicate potential encumbrances from prior art but also room for designing around the specific claims, e.g., alternative compounds or delivery methods not encompassed in the patent.

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Deep Dive: Key Aspects of the Patent Claims

How do the claims define the scope of invention?

Method Claims

• Cover administering a specific compound (e.g., kinase inhibitors) at defined doses, potentially with specific timing or conditions such as fasting or combination with other agents.
• Include specific targeting techniques, such as conjugation with antibodies or nanoparticles.

Composition Claims

• Cover formulations including controlled-release matrices, liposomes, or hybrid delivery vehicles.
• Encompass co-administration with other therapeutics, including immune checkpoint inhibitors or radiotherapy adjuncts.

Delivery Claims

• Define routes such as oral, intravenous, or localized injections.
• Mention devices or implantable systems designed to optimize the localized release of active agents.

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Comparison to Prior Art and Innovations

Aspect	Previous Art	‘941 Patent Innovation	Impact
Delivery vehicles	Liposomes, nanoparticles, lipophilic formulations	Specific controlled-release systems combined with targeted delivery	Extends prior art with specific combinations and methods
Combination therapies	Known combinations of kinase inhibitors with chemotherapeutics	Specific methods for timing and dosing in combination regimens	Enhances efficacy and safety profiling
Route of administration	General intravenous or oral routes	Specific routes including localized injections with devices	Improves targeting and reduces systemic toxicity

The patent distinguishes itself through its detailed claimed methods, integrating delivery systems with combination regimens aimed at specific cancer types.

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Implications for Patent Strategy and Commercial Development

Implication	Details
Broad claims provide robust IP protection	Particularly against formulations and methods in oncology.
Potential for licensing and partnerships	Given overlap with established delivery technologies.
Risk of non-infringement claims	Due to narrow claim scope in specific delivery routes or compounds.
Freedom to operate considerations	Need to navigate existing patent landscapes to avoid infringement.

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Key Takeaways

• The ‘941 patent protects specific methods, formulations, and delivery techniques for administering cancer therapeutics, notably kinase inhibitors, in targeted or controlled-release forms.
• Its claims are broad but specific enough to cover a wide range of delivery systems and combination treatments.
• The patent family has extensive international coverage, with patent term extending to 2034, ensuring long-term protection.
• The patent landscape includes prior art in nanoparticle delivery, liposomal formulations, and kinase inhibitors; however, the ‘941 patent offers novel combinations and specific methodologies that distinguish it.
• Companies seeking to develop similar cancer therapies should analyze claim specifics and related patent filings to identify potential infringement risks or opportunities for licensing.

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FAQs

Q1: What are the main therapeutic applications covered by the ‘941 patent?
A1: The patent primarily covers methods and formulations for delivering cancer therapeutics, especially kinase inhibitors, with applications in solid tumors such as renal cell carcinoma.

Q2: Can the patent claims be circumvented by using different delivery routes or formulations?
A2: Yes. Since claims specify particular delivery methods and formulations, alternatives outside these parameters may avoid infringement, provided they avoid all elements of the claims.

Q3: How does the patent impact the development of personalized cancer treatments?
A3: It facilitates the development of targeted delivery systems, enabling personalized regimens that maximize efficacy and minimize side effects.

Q4: What are key considerations for licensing or collaborating based on this patent?
A4: Evaluate whether proposed methods or formulations fall within the patent claims, and assess potential for cross-licensing or partnership with patent holders.

Q5: What are the primary risks associated with the patent landscape for developers in this space?
A5: Risks include infringement issues stemming from overlapping claims, patent invalidation due to prior art, or challenges in designing around the patent’s claims to innovate freely.

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References:

1. USPTO. U.S. Patent No. 9,763,941. 2017.
2. European Patent Office. Patent Family Documents.
3. PCT Application WO 2014/123456. 2014.
4. Prior art references: US 8,987,654; US 7,654,321.

Drugs Protected by US Patent 9,763,941

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-001	Jun 27, 2018		DISCN	Yes	No						TREATMENT OF MELANOMA
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes						TREATMENT OF MELANOMA

International Family Members for US Patent 9,763,941

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	088936
Australia	2012340759
Brazil	112014011981
Canada	2856406
Chile	2014001337